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Post by agedhippie on Feb 20, 2024 18:39:51 GMT -5
I can't remember from which presentation it was but there was a slide showing about 65 - 70% of Tyvaso users are on now on DPI. Killing some time here till UTHR's earnings call on Wednesday, but any guesses on what the new and improved rate will be? It was 63% for Q3, 2023. Re: Aged's comment about PH-ILD. Uptake of TDPI for this indication was affected by Medicare/insurance coverage throughout 2023. I think that PAH and PH-ILD are primarily covered via Medicare Part B which means insurers don't get a say. Also why they don't show up in Symphony.
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Post by agedhippie on Feb 20, 2024 18:35:44 GMT -5
I suppose I should be clearer. I think Afrezza is a perfectly viable treatment for kids, especially older kids. What I am saying here is what the endos are going to say. They want to see a superior TIR for Afrezza before they start to use it in earnest. Superior post prandial spike handling is nice, but it's only part of the picture and they are concerned with the whole picture including the load it puts on the kids and their parents. Think of the patient Stevil had who Stevil put on Afrezza and came back not because of cough or anything else, but because he wanted a simpler solution. Do not under-estimate that aspect.
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Post by agedhippie on Feb 20, 2024 18:24:49 GMT -5
That still doesn't fix the nighttime numbers as you pointed out before.
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Post by agedhippie on Feb 20, 2024 18:24:03 GMT -5
Let's compromise. CGM 24 hrs/day, 1 basil shot administered by parent in the morning, Afrezza for meals. No pump. That was the protocol used for STAT-1 and it failed to deal with the nighttime highs. That was the point the mother was making about disrupted sleep for both her and her child to deal with those. That said a daily basal plus Afrezza would be the go-to protocol for kids using Afrezza.
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Post by agedhippie on Feb 20, 2024 8:47:15 GMT -5
Aged - you are making my point - "for the first time since the diagnosis I can relax,” she says. The time Sofia spends within her target blood glucose range has improved and it is much easier now to control her levels. “It’s a complete weight off my shoulders.” Post prandial spikes and hypos when they are sleeping has these moms on edge. Afrezza should be able to solve both these issues plus the big one for the kids. They don't want to wear them. The only issue will be cost. ... The highlighted paragraph is where the problem lies. As you have repeatedly pointed out it is unfair to Afrezza to expect it to manage overnight levels since it is long gone by then. It is not going to fix the problem for these parents. The problem isn't so much the post prandial control, which is obviously important, but the holistic control. It's no good saying the meal time is fine but I have to watch like a hawk for the rest of the day (and night).
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Post by agedhippie on Feb 19, 2024 22:57:29 GMT -5
I read it prior. Its a significant difference for the kids/moms than what they had so sure its great but you did not fully read my comment. Afrezza is a game changer for them. They have nothing like it right now. The biggest issue they currently have is when they eat and dosing for that and then having too much on board when they go to bed. Afrezza should solve both these issues for them. With their biggest issues solved and their kid does not want to wear the pump, afrezza solves that problem too. Is afrezza perfect - no. For T1s its some times too fast and they need to take follow-ups. Al Mann really saw it more for the T2s and many many never thought it would get approved for T1s. Now, its the T1s pushing for it while its being hidden from the T2s. As I said before the cartridges should have been called small, medium and large vs 4u, 8u, 12u as this marketing blunder because these T1s have a really hard time getting over the afrezza dosing. I am also surprised they never came out with a Xsmall the 2u for the kids. In some cases T1s tried it and said this afrezza is not for me. Ginger Viera is a great example. It was about four years ago she had little desire to use afrezza. In fact I think she said she tried it and was not too impressed. Now that she understands afrezza dosing and follow-ups she might be the biggest T1 afrezza cheerleader. From a user base size with the T1s it is picking up but cost is the biggest issue. Cost will be the biggest issue for the kids so BP will do what they can to deny insurance and keep it away from the kids. If the moms can afford it the pumps won't be able to compete. Using the CamAPS, which is the standard UK APS, kids had a TIR of 71%, and an A1c of 6.6%. That's the benchmark. The commercial pumps like the 780G are even better. This statement from a parent is why doctors put kids on pumps: “I have full trust in the CamAPS FX app and I feel like for the first time since the diagnosis I can relax,” she says. The time Sofia spends within her target blood glucose range has improved and it is much easier now to control her levels. “It’s a complete weight off my shoulders.”
It's sharing responsibility, the parent is no longer solely responsible for the kid. The pump does the work and the parent monitors. It's going to be a heavy lift to get doctors to go back to MDI for kids from these devices.
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Post by agedhippie on Feb 19, 2024 17:36:02 GMT -5
I can't remember from which presentation it was but there was a slide showing about 65 - 70% of Tyvaso users are on now on DPI. Killing some time here till UTHR's earnings call on Wednesday, but any guesses on what the new and improved rate will be? It's an interesting question. I think there are two parts; the conversion from cannibalizing the existing Tyvaso Nebulizer users, and net new users. My suspicion is that we must be nearing the upper limit for conversions so it's going to be down to net new. The most interesting number if the give it is the PH-ILD user growth because that is entirely net new as I understand it.
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Post by agedhippie on Feb 19, 2024 14:10:06 GMT -5
Aged - about what percentage of kids do you think wants to wear a pump? I would say close to 0%... No, I would say absolutely zero. Aside from a few bodybuilders I have never met anyone who wanted to take insulin be it injected, pump, inhaled or any other way. I certainly don't. But if that's what it takes to keep you alive (or your kid) then you will adapt. Insulin isn't a lifestyle choice. Read the article I posted the link to, see what the parent and kid got out of the pump, and then comment.
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Post by agedhippie on Feb 19, 2024 11:48:03 GMT -5
The reporter said that Cincinnati Children’s is accepting patients for the trial (INHALE-1) through Feb. But, four days ago, MNKD announced the study is fully enrolled. Can they still add enrollees now or just put them on a waiting list in case of drop-outs? They cannot add patients at this point, nor would they want to since it would delay the results. Drop-outs don't get replaced.
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Post by agedhippie on Feb 18, 2024 16:34:41 GMT -5
If you want to understand the competition in the pediatric diabetes options this is the story of a 6 year old and an AID pump. www.cam.ac.uk/stories/KidsArtificialPancreasThe CamAPS is the UK equivalent of the Omnipod 5/Tandem/Medtronic 780G AID systems and is the preferred AID pump in the UK. The description of how she was finding life on the pump, and the change in the parent's life, is why endos use these pumps. I assume pumps do not prevent prandial excursions. Is that a good assumption? If so, I'm excited at the possibility of Afrezza being a useful tool in the toolkit of children on pumps. Pumps absolutely will not prevent prandial excursions. I think the best way to see this is Afrezza as handling the micro view, and pumps handling the macro view. Afrezza will smack down the prandial excursion, and the pump will handle things when Afrezza has worn off. My aim with that article is to show how pumps are seen by patients and endos.
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Post by agedhippie on Feb 18, 2024 14:31:06 GMT -5
If you want to understand the competition in the pediatric diabetes options this is the story of a 6 year old and an AID pump. www.cam.ac.uk/stories/KidsArtificialPancreasThe CamAPS is the UK equivalent of the Omnipod 5/Tandem/Medtronic 780G AID systems and is the preferred AID pump in the UK. The description of how she was finding life on the pump, and the change in the parent's life, is why endos use these pumps.
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Post by agedhippie on Feb 16, 2024 15:08:45 GMT -5
Why does it say "treat most adults" instead of "treat all adults"? Is there an alternative to insulin? That is a reference on how insulin is taken rather than taking insulin. Prior to MDI you used a fixed ratio insulin (MIX) that was a combined basal and bolus insulin. It was taken a couple of times a day and you relied on the peaks in the insulins to cover meals. It was as bad as it sounds since there was no flexibility at all. They still use this even today and for the last week there is Symphony data TRx was 48,920 which is frankly horrifying. You can do MDI using Regular and NPH, and indeed that was how it was done for the UKDPS trial.
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Post by agedhippie on Feb 13, 2024 9:43:44 GMT -5
Oh so you think so - sure. Why did Brandicourt kill afrezza day 1? Why didn't DeSisto show up? What happened to Dave Kendall right before Mounjarno results right when he was just starting to make some waves? Why is "inhaled insulin" in parentheses in the SoC? 50k was Bill from VDex's number. I think its a good start and 50x more than we have now. ... Why did Brandicourt kill Afrezza day 1? - Because Afrezza was not getting the predicted sales and from their data Brandicourt did not believe it would recover based on his experience with Exubera. Whether he was right or wrong that is a perfectly valid call and why you employ experienced executives. Compounding this was the need for resources to protect their basal insulin franchise with the expiry of the Lantus patent. Why didn't DeSisto turn up? - Because the Insulet board were really upset with DeSisto and had fired him for mis-management of Insulet so they were not inclined to play nice and threatened to sue for breach of non-competes. MNKD didn't want to get into a lawsuit over it's CEO so they withdrew the offer. It is worth noting that ten years later he has not got a new CEO job. What happened to Dave Kendall right before Mounjarno results right when he was just starting to make some waves? - He joined Zealand which was a better fit. MNKD was not doing trials because there was no money so really there was nothing for him to do. Why is "inhaled insulin" in parentheses in the SoC? - If that is a serious question I feel the bottom of the barrel is being scraped. It's in parentheses in one place and somehow there is a big conspiracy? No endo will care. I am well aware that this is probably a pointless response since the conspiracy justification is an article of faith but I thought I would state the conventional reasons.
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Post by agedhippie on Feb 12, 2024 17:27:00 GMT -5
Just search on mark cuban and insulin, you don't need anything else and you will get lots of hits. I think they know exactly what they are doing; read the quote. Insulin is off the table. Why do you keep lumping afrezza in with insulin? It is not. Its the greatest advance in diabetes care since Banting and Best. ... When is Mike going to pull out the old studies done on afrezza refrigeration and get the refrigeration removed too? Does anyone refrigerate afrezza? I doubt it. ... Let me see... The Afrezza label - "AFREZZA® (insulin human) Inhalation Powder". That looks like insulin to everyone else. Mike can get the need for refrigeration removed any time he wants, he just needs to do the required trials and prove it is shelf-stable. Until then it has to be refrigerated when it is shipped. Let me know when it happens because I doubt it will be soon.
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Post by agedhippie on Feb 12, 2024 17:21:28 GMT -5
What he said was they had severe nausea. Then he said he never said it. Then when showed he said it he said it but it was his phones fault. He also said he gives them another med to deal with the nausea and that helps too. I am going with Calley over Stevil even though Calley is not a doctor but his sister is, not that that matters. ... Go back and read all of what stevil said. You go with Calley, who doesn't even play a doctor on TV, for medical advice. Me? I prefer an actual doctor who is in the trenches.
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